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2018 Technical Education Program

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  • CRB Tech Tank: Solving demand allocation problem with modeling and simulations

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    For a multi-site organization, allocating demands can be a challenging problem. Computer simulations, in conjunction with mathematical modeling, can be used to ...

    • Language: English

  • Risk analysis: Present state and industry's demand

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Risk analysis: Present state and industry's demand Dr. A. Fedotov, Clean Technologies LLC, Moscow, Russia 1. ICH Q9/EU GMP on risk analysis – are they correct ...

    • Language: English

  • Case Study: Capacity Expansion and Conversion to Single-Use BioProcessing at an Existing cGMP CDMO Facility

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    With growing demand in the biologics CDMO market, Merck KGaA (Darmstadt, Germany) elected to expand capacity at its existing cGMP biomanufacturing facility in M...

    • Language: English

  • A Case Study for an Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    One of the key areas for ensuring that cleanrooms remain within microbiological and particulate specifications as laid out in ISO 14644 or Annex 1 of GMP is dis...

    • Language: English

  • "The Impact of Critical Utilities"

    04/17/2018, 3:45 PM - 4:30 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Settling the Frontier of Fill-Finish Operations – High Tech Filling in a Proper Abode

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Fill/finish operations represent perhaps the last frontier of significant risk in manufacturing injectable medicines. Closed systems in compounding and formulat...

    • Language: English

  • Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as ...

    • Language: English

  • Integrating IoT into your Life Sciences Packaging and Supply Chain Strategy - Best Practices to Take this Valuable Leap

    04/17/2018, 4:15 PM - 5:00 PM, INTERPHEX Innovation Stage

    In today's world, technology is advancing every second. The Internet of Things phenomenon has enabled groundbreaking advances in connected devices and personali...

    • Language: English

  • Continuous OSD: Designing a Controls Model

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed proc...

    • Language: English

  • A Novel, Real Time Adaptive Process Control System for Optimizing Feeding in Bioreactors

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    An in-line process monitoring system and method for in-situ, real time monitoring and control of nutrient and carbon source feeding in bioreactors is described....

    • Language: English

  • "Show Wrap Up Day 1"

    04/17/2018, 4:30 PM - 4:45 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Data-driven Control Strategy for Critical Drug Container Closure Systems (CCS) Performance at Digital Age

    04/18/2018, 12:00 AM - 1:00 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The container closure integrity (CCI) performance is essential for drug product quality throughout the entire sealed drug product life cycle, and it is predomin...

    • Language: English

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